Apparatus, method and system for determining a physiological condition within a mammal

ABSTRACT

A system, method and apparatus for determining a physiological condition within a mammal based on pH and/or temperature measurements. In one aspect, the invention is directed to a method of determining vaginal health and/or fertility status in a female mammal comprising: a) inserting a probe into a vagina of the female mammal, a distal portion of the probe comprising an ISFET for measuring pH and a temperature sensor for measuring temperature; b) measuring pH and temperature with the ISFET and the temperature sensor of the probe; c) transmitting signals indicative of the measured pII and temperature to a microprocessor; d) the microprocessor generating an output signal indicative of the fertility and/or vaginal health status in the female mammal based on the signals indicative of the measured pH and temperature; and e) communicating the output signal to a user.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present application claims the benefit of United States ProvisionalPatent Applications Ser. No. 61/086,403, filed Aug. 5, 2008, and Ser.No. 61/231,076, filed Aug. 4, 2009, the entireties of which are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to the field of determining aphysiological condition within a mammal, and specifically to apparatus,methods and systems of determining a physiological condition within amammal based on pH measurements of biological fluids taken either invivo or externally, such as ovulation, vaginal and/or cervical health,and other physiological conditions.

The device is particularly suited for insertion into the vagina butallows for easy pH measurement of small samples of various other bodilyfluids (urine, saliva, blood) external of the body. The device shown isdesigned for female end user self testing but can also be a valuable aidin physicians offices and clinical labs. The invention can be used forvarious mammals, including human and veterinary applications.

BACKGROUND OF THE INVENTION

pH is a measure of the acidity of alkalinity of a solution or substance.Solutions with a pH less than seven are considered acidic, while thosewith a pH greater than seven are considered basic or alkaline. A pHlevel of 7.0 is considered neutral. When a pH level is 7.0, it isdefined as ‘neutral’ because at this pH the concentration of H₃O⁺ equalsthe concentration of OH³¹ in pure water. The pH value is a measure ofthe activity of hydrogen ions in the solution. The pH scale is typicallybetween 1 and 14 with 1 being the most acidic and 14 the most alkaline.The pH scale is an inverse logarithmic representation of hydrogen protonconcentration. Therefore a value change of 1 pH unit represents a factorof 10 increase or decrease.

The vagina is the muscular canal extending from the vaginal opening tothe cervix and consists of three layers of tissue. The mucosa is thesurface layer and consists of mucus membranes. The next layer of tissueis a layer of muscle concentrated mostly around the outer third of thevagina. The third layer is the innermost layer and consists of fibroustissue.

The vagina contains folds or wrinkles rather than a smooth surface. Itis usually about 3 to 5 inches in length and its walls are lined with amucus membrane. The vagina includes numerous tiny glands that generatevaginal secretions/fluids. The vaginal walls are continually producingsecretions/fluids necessary to provide lubrication, to cleanse thevagina and to maintain the proper acidity to prevent infection. Thevagina tends to be fairly acidic usually in the range of 3.5 to 4.5 pH.The walls of the vagina are normally in contact with each other, whichis contrary to most anatomical illustrations. When something enters thevagina, its walls separate to make room for the object. Because of itsmuscular tissue, the vagina has the ability to expand and contractadjusting to fit snugly around the object inserted.

Accurate monitoring of vaginal pH is an important part of in thediagnosis of vaginal infections such as Bacterial Vaginitis (BV). Thenormal vaginal pH in reproductive age women is usually 3.5 to 4.5. Avalue greater the 4.5 can indicate a variety of vaginal infections whichare usually accompanied by unusual discharge, itching, burning andirritation. The three diseases most frequently associated with vaginaldischarge are BV, trichomoniasis (caused by a sexually transmittedinfectious parasite), and candidiasis (usually caused by Candidaalbicans).

Bacterial vaginosis (BV) is the most common cause of vaginal infection.BV is caused by an imbalance of naturally occurring bacterial flora. Tocontrol bacterial growth, the vagina is normally slightly acidic with apH of 3.5-4.5. A pH greater than 4.5 is considered alkaline and issuggestive of bacterial vaginosis.

Candidiasis, also known as a “yeast infection” or VVC, is a commonfungal infection that occurs when there is overgrowth of the funguscalled Candida. Candida is always present in the body in small amounts,however when an imbalance occurs, such as when the normal acidity of thevagina changes or when hormonal balance changes, Candida can multiply.When that happens, symptoms of candidiasis appear.

Trichomoniasis, sometimes referred to as “trich,” is a common cause ofvaginitis. Trichomoniasis is primarily an infection of the urogenitaltract with the most common site of infection the vagina or urethra inwomen. With a trichomonas infection, the vagina is likely to be morealkaline than normal. An estimated five million cases of trichomoniasisoccur each year in the United States. Men also can contracttrichomoniasis however do not often have signs or symptoms. Some men maytemporarily have an irritation inside the penis, mild discharge, orslight burning after urination or ejaculation.

According to the Centers for Disease Control (CDC), there are someserious risks from BV such as;

-   -   An increase in a woman's susceptibility to HIV infection if she        is exposed to HIV virus.    -   An increase in the chances that an HIV-infected woman can pass        HIV to her sex partner.    -   An increase in a woman's susceptibility to other STDs, such as        herpes simples virus (HSV) Chlamydia and gonorrhea.    -   An increase in the development of an infection following        surgical procedures such as a hysterectomy or an abortion.    -   During pregnancy, an increase in adverse pregnancy outcomes has        been detected, including premature rupture of the membranes,        preterm labor, preterm birth, intraamniotic infection, and        postpartum endometritis.

The results of several investigations indicate that treatment ofpregnant women with BV who are at high risk for preterm delivery (i.e.,those who previously delivered a premature infant) might reduce the riskfor prematurity. Monitoring of pH level during pregnancy is an importantcriterion in reducing the incidences of Preterm labor and birth. Studieshave shown that bacterial vaginosis was associated with the pretermdelivery of low-birth-weight infants independently of other recognizedrisk factors. Reduction in the instances of pre-mature birth improvesthe health of the newborn and significantly reduces the cost of care.

Oral clindamycin prevents spontaneous preterm birth and mid trimestermiscarriage in pregnant women with bacterial vaginosis. Based onestimates from the CDC, the number of pregnant women in the UnitedStates alone that are annually infected with BV is 1,080,000 andTrichomoniasis is 124,000.

Untreated bacterial vaginosis is a risk factor for post abortion pelvicinflammatory disease (PID). Studies have shown that preabortal screeningand subsequent treatment of those who test clinically positive doeslower the incidence of postabortion PID.

BV can be diagnosed by the use of clinical criteria or Gram stain. Inclinical practice BV is diagnosed using the Amsel criteria. Clinicalcriteria require typically three of the following symptoms or signs:

-   -   homogeneous, thin, white discharge that smoothly coats the        vaginal walls;    -   presence of clue cells on microscopic examination;    -   pH of vaginal fluid >4.5; and    -   a fishy odor of vaginal discharge before or after addition of        10% KOH (i.e., the whiff test).

Current methods of monitoring vaginal pH include various methods ofchecking pH paper type products. The accuracy of these products aregenerally in the range of 0.3 pH to 0.5 pH. They generally require theuser to subjectively compare color in order to determine the pII valueand are subject to inaccuracies. Inaccuracies can be due to lightingconditions or the ability of the user to accurately compare color.Manual recording of the subjective readings is required.

The cervix is the lower portion of the uterus and forms the neck of theuterus. The cervix joins with the top end of the vagina and the uterinecavity. The cervix protrudes into the vagina and this area is called theectocervix. Typically the ectocervix is about 2.5 to 3 cm in diameterand has an elliptical surface. The ectocervix is also called theexternal os. The size and shape of the external os can vary widelydepending on the age of the woman or if she has given vaginal birth. Thepassage way between the external os and the uterus is referred to as theendocervical canal. The endocervical canal terminates at the internal oswhich is the opening of the cervix inside the uterine cavity. Thecervical canal of the uterus is covered by a thin layer of mucus.Pockets within the lining of the cervix function to produce cervicalfluid.

Studies by George I. Gorodeski et al, such as those disclosed in U.S.Patent Application US/2008/0071 190 published Mar. 20, 2008, show thatcervical pH changes dramatically during the ovulation cycle while thevaginal pH remains relatively constant. The in-vivo vaginal and cervicalpH values recorded were measured in Gorodeski by attaching a strip ofpHydrion paper at the tip of uterine forceps. In addition, another morecomplicated clinical lab test was preformed by measuring cell culturesof the human Ecto-cervical Epithelial cells and human Endocervicalcells. These tissue samples were collected and then analyzed andmeasured using an elaborate clinical procedure. Using these techniques,it was shown that the pH of the ectocervix changes as much as 2 pHduring the ovulation cycle with the peak occurring during days 11-14 ofthe cycle (ovulation period). During the same periods the vaginalreadings remained relatively constant.

Studies have also shown that monitoring of vaginal pH can be a goodindicator of menopause in women who are without vaginitis and are notreceiving estrogen therapy. A pH reading greater than 4.5 could indicatemenopause and the need for estrogen therapy. Low levels of estrogen cancause elevated pH levels in the area of 6.0 or higher. The sensitivityof FSH blood work was no different than vaginal pH in the diagnosis ofmenopause. Estrogen causes deposition of glycogen in mature epithelialcells, which is then converted by bacterial enzymes to glucose. Theglucose is anaerobically fermented to lactic acid, which gives thevagina a pH of 3.5 to 4.5.

Further studies have shown that an important function of the vaginal andcervical epithelial cells is to regulate the pH of the lumen of thelower genital tract. During premenopausal years vaginal luminal pHranges between 4.5 and 6.0 with mild alkalinization to about 6.5 beforeovulation. Lack of estrogen, such as after menopause, is associate withalkalinization to about 6.5-7.0, whereas replacement with estrogen canacidify the luminal vaginal pH to about 5.5.

On a related note, there are times when urine pH can indicate serioushealth issues. For example, a very high (alkaline) urine pH could becaused by kidney failure or a urinary tract infection. A very low(acidic) urine pH could be the result of lung disease, complications ofdiabetes, starvation, or diarrhea. The glomerular filtrate of blood isusually acidified by the kidneys from a pH of approximately 7.4 to a pHof about 6 in the urine. Depending on the person's acid-base status, thepH of urine may range from 4.5 to 8. The kidneys maintain normalacid-base balance primarily through the reabsorption of sodium and thetubular secretion of hydrogen and ammonium ions. Urine becomesincreasingly acidic as the amount of sodium and excess acid retained bythe body increases. Alkaline urine, usually containingbicarbonate-carbonic acid buffer, is normally excreted when there is anexcess of base or alkali in the body. Secretion of acidic or alkalineurine by the kidneys is one of the most important mechanisms the bodyuses to maintain a constant body pH.

A highly acidic urine pH occurs in:

-   -   Acidosis    -   Uncontrolled diabetes    -   Diarrhea    -   Starvation and dehydration    -   Respiratory diseases in which carbon dioxide retention occurs        and acidosis develops

A highly alkaline urine occurs in:

-   -   Urinary tract obstruction    -   Pyloric obstruction    -   Salicylate intoxication    -   Renal tubular acidosis    -   Chronic renal failure    -   Respiratory diseases that involve hyperventilation (blowing off        carbon dioxide and the development of alkalosis)

Urine pH is often used to monitor a person's diet. In people who are notvegetarians, the pH of urine tends to be acidic. A diet rich in citrusfruits, legumes, and vegetables raises the pH and produces urine that ismore alkaline. Generally an accurate measurement of urinary pH can bedone only on a freshly voided specimen. If urine pH is to be useful, itis necessary to use pH information in comparison with other diagnosticinformation.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide anapparatus, system and method for determining one or more physiologicalconditions within a mammal based on pH measurements, including withoutlimitation one or more of the physiological conditions discussed above.

Another object of the present invention is to provide an apparatus,system and method for measuring pH and temperature of a biologicalfluid.

Yet another object of the present invention is to provide an apparatus,system and method for determining a physiological condition within amammal based on either in vivo or external measurements of biologicalfluids.

Still another object of the present invention is to provide anapparatus, system and method for determining a physiological conditionwithin a mammal that requires minimal calibration.

A further object of the present invention is to provide an apparatus,system and method for determining a physiological condition within amammal that utilizes a replaceable “plug-and-play type” of probe.

A yet further object of the present invention is to provide anapparatus, system and method for determining a physiological conditionwithin a mammal that utilizes a dark environment for calibration.

A still further object of the present invention is to provide anapparatus, system and method for determining a physiological conditionwithin a mammal that utilizes an ion-sensitive field effect transistor(ISFET) for measuring pH.

An even further object of the present invention is to provide anapparatus, system and method for determining a physiological conditionwithin a mammal wherein the processing and logic circuitry is maintainedin a handle and a minimal amount of circuitry is maintained in areplaceable probe.

Another object of the present invention is to provide an apparatus,system and method for determining the fertility status of a femalemammal.

Yet another object of the present invention is to provide an apparatus,system and method for predicting ovulation in a female mammal based oncurrent and stored pH and/or temperature measurements.

These and other objects are met by the present invention which, in oneaspect, is an apparatus for measuring a physiological condition within amammal comprising: an elongated probe for insertion into a body lumen ofthe mammal, the probe comprising a first circuit board operably couplinga pH sensor for measuring pH within the body lumen and generating a pHsignal indicative of the measured pH, a memory device storing parametricdata unique to the pH sensor, and a first interface connector located ata proximal portion of the probe; a handle for manipulating the probe,the handle comprising a second circuit board operably coupling amicroprocessor for processing the pH signal and generating an outputsignal based on the processing of the pH signal, a display device fordisplaying the output signal generated by the microprocessor, and asecond interface connector; the probe connected to the handle in mannerthat allows the probe and handle to be repetitively engaged anddisengaged from each other; and wherein when the probe is connected tothe handle, the first and second interface connectors are in electricalconnection so that the microprocessor can retrieve the parametric datafrom the memory device of the probe and receive the pH signal.

In another aspect, the invention can be an apparatus for measuring aphysiological condition within a mammal comprising: an elongated probefor insertion into a body lumen of the mammal, the probe comprising afirst circuit board operably coupling an ion-sensitive field effecttransistor (ISFET) for measuring pH within the body lumen and generatinga pH signal indicative of the measured pH, a temperature sensor formeasuring temperature within the body lumen and generating a temperaturesignal indicative of the measured temperature, a diaphragm in contactwith an electrolyte solution buffered at a known pH, a memory devicestoring ISFET slope data at both ambient temperature and normal bodytemperature for the ISFET, and a first interface connector located at aproximal portion of the probe; a handle for manipulating the probe, thehandle comprising a second circuit board operably coupling amicroprocessor for receiving the pII and temperature signals andgenerating an output signal based on the processing of the pH andtemperature signals and the ISFET slope data, a display device fordisplaying the output signal generated by the microprocessor, and asecond interface connector; the probe connected to the handle in mannerthat allows the probe and handle to be repetitively engaged anddisengaged from each other; and wherein when the probe is connected tothe handle, the first and second interface connectors are in electricalconnection so that the microprocessor can retrieve the ISFET slope datafrom the memory device of the probe and receive the pH and temperaturesignals.

In yet another aspect, the invention can be an apparatus for measuring aphysiological condition within a mammal comprising: a probe forinsertion into a body lumen of the mammal, the probe comprising: anelongated tubular housing extending along a longitudinal axis from aproximal end to a distal end, the elongated tubular housing having afirst internal cavity; a first circuit board located within the firstinternal cavity; a pH sensor for measuring pH within the body lumenlocated at a distal portion of the elongated tubular housing, the pHsensor generating a pH signal indicative of the measured pH and operablycoupled to the first circuit board; a temperature sensor for measuringtemperature within the body lumen located at the distal portion, thetemperature sensor generating a temperature signal indicative of themeasured temperature and operably coupled to the first circuit board; afirst memory device storing parametric data unique to the pH sensor, thememory device housed within the internal cavity of the elongated tubularhousing and operably coupled to the first circuit board; and a firstinterface connector located at a proximal portion of the elongatedtubular housing and operably coupled to the circuit board; a handle formanipulating the probe, the handle comprising: a second housing having asecond internal cavity and a socket forming a passageway into the secondinternal cavity; a second circuit board located within the secondinternal cavity; a microprocessor located within the second housing andoperably coupled to the second circuit board for receiving andprocessing the pH signal and the temperature signal, the microprocessorgenerating an output signal based on the processing of the pH signal andthe temperature signal and the parametric data; a power source locatedwithin the second housing and operably coupled to the second circuitboard; user controls located on the second housing and operably coupledto the second circuit board; a display device operably coupled to thesecond circuit board for displaying the output signal generated by themicroprocessor; a second interface connector operably coupled to thecircuit board and aligned with the socket; and wherein the probe isremovably secured to the handle, the proximal portion of the elongatedtubular housing extending into the socket of the second housing so thatthe first and second connectors are in electrical connection.

In still another aspect, the invention can be an apparatus for measuringa physiological condition within a mammal comprising: an elongatedtubular housing extending along a longitudinal axis from a distal end toa proximal end, the housing having an internal cavity; a first openingin the elongated housing forming a first passageway into the internalcavity; an ISFET for measuring pH within a body lumen of the mammal, theISFET positioned in the internal cavity, the ISFET aligned with thefirst opening so that at least a portion of the ISFET is exposed via thefirst opening; and a first seal between the ISFET and the housingforming a hermetic seal about a perimeter of the first opening.

In a further aspect, the invention can be an apparatus for measuring aphysiological condition within a mammal comprising: an elongated tubularhousing extending along a longitudinal axis from a distal end to aproximal end; and an ISFET for measuring pH within a body lumen of themammal, the ISFET located on a distal portion of the housing and havingat least a portion of the ISFET exposed for contact with fluid of thebody lumen.

In a yet further aspect, the invention can be an apparatus for measuringa physiological condition within a mammal comprising: an elongatedtubular housing extending along a longitudinal axis from a distal end toa proximal end; an ion-sensitive field effect transistor (ISFET) formeasuring pH within a body lumen of the mammal, the ISFET located on adistal portion of the housing and having at least a portion of the ISFETexposed; a temperature sensor for measuring temperature within the bodylumen, the temperature sensor located on a distal portion of the housingand having at least a portion of the temperature sensor exposed; amemory device storing parametric data unique to the pH sensor, theparametric data includes first ISFET slope data determined at ambienttemperature and second ISFET slope data determined at normal bodytemperature; a first interface connector operably coupled to the ISFET,the temperature sensor and the memory device, the first interfaceconnector located at the proximal end of the housing; and a firstcircuit board located within the housing, the ISFET, the temperaturesensor, the memory device and the first interface connector operablycoupled to the first circuit board.

In a still further aspect, the invention can be an apparatus formeasuring a physiological condition within a mammal comprising: anelongated housing extending along a longitudinal axis from a proximalend to a distal end, the housing having an internal cavity; a transversewall extending along the longitudinal axis that separates the internalcavity into a first chamber and a second chamber, the first and secondchamber isolated from one another and extending in an axial adjacentmanner along the longitudinal axis; a par-cylindrical cutout in theelongated housing forming an open end of the first chamber and exposinga portion of the transverse wall; a pH sensor for measuring pH within abody lumen of the mammal and a temperature sensor for measuringtemperature within the body lumen, the pH sensor and the temperaturesensor located on the exposed portion of the transverse wall; apar-cylindrical cover having a well for collecting biological fluids,the well having an annular wall and a floor, and first and secondopenings forming first and second passageways through the floor of thewell respectively; and the par-cylindrical cover secured to theelongated housing so that the pH sensor is exposed via the first openingand the temperature sensor is exposed via the second opening, thepar-cylindrical cover covering the par-cylindrical cutout so as tohermetically seal the open end of the first chamber.

In an even further aspect, the invention can be an apparatus formeasuring a physiological condition within a mammal comprising: anelongated housing extending along a longitudinal axis from a proximalend to a distal end, the housing having an internal cavity; a transversewall separating the internal cavity into a first chamber and a secondchamber; a cutout in the elongated housing forming an opening into thefirst chamber and exposing a portion of the transverse wall; a pH sensorfor measuring pH within a body lumen of the mammal and a temperaturesensor for measuring temperature within the body lumen, the pH sensorand the temperature sensor located on the exposed portion of thetransverse wall; a cover having a well for collecting biological fluids,first and second openings forming first and second passageways through afloor of the well; and the cover secured to the elongated housing sothat the pH sensor is exposed via the first opening and the temperaturesensor is exposed via the second opening, the cover covering the cutoutso as to hermetically seal the opening into the first chamber.

The invention may also, in one aspect, be an apparatus for measuring aphysiological condition within a mammal comprising: an elongated housingextending along a longitudinal axis from a proximal end to a distal end,the housing having an internal cavity; a wall within the internalcavity; a cutout in the elongated housing forming an opening into theinternal cavity and exposing at least a portion of the transverse wall;a pH sensor for measuring pH within a body lumen of the mammal andlocated on the exposed portion of the transverse wall; a cover having afirst opening forming a first passageway through the cover; and thecover secured to the elongated housing so that the pH sensor is exposedvia the first opening, the cover covering the cutout so as tohermetically seal the opening into the internal cavity.

In another aspect, the invention can be a system for measuring aphysiological condition within a mammal comprising: an apparatuscomprising: an elongated housing extending along a longitudinal axisfrom a proximal end to a distal end; a pH sensor for measuring pH withina body lumen of the mammal, the pH sensor located at a distal portion ofthe elongated housing; a temperature sensor for measuring temperaturewithin the body lumen, the temperature sensor located at the distalportion of the elongated housing; and a handle having a second housingfor manipulating the elongated housing, the second housing having a topsurface, a bottom surface and a plurality of lateral surfaces boundingthe top and bottom surfaces, the elongated housing protruding from oneof the lateral surfaces of the second housing; a removable cap forenclosing the distal portion of the elongate housing, the capcomprising: a base having a first channel in a top surface of the base;a lid having a second channel in a bottom surface of the lid; andwherein when the removable cap is in a closed position, the lid ispositioned atop the base so that the bottom surface of the lid opposesthe top surface of the base and the first and second channels form acavity having an open end and a closed end; and wherein when theremovable cap is secured to the elongated housing in the closedposition, the distal portion of the elongate housing nests within thecavity and a remaining portion of the elongated housing protrudes fromthe open end of the cavity.

In yet another aspect, the invention can be a system for measuring aphysiological condition within a mammal comprising: an apparatuscomprising: an elongated housing extending along a longitudinal axis; apH sensor for measuring pH within a body lumen of the mammal, the pHsensor located at a distal portion of the elongated housing; and asecond housing for manipulating the elongated housing, the elongatedhousing protruding from the second housing; a removable cap forenclosing the distal portion of the elongate housing, the capcomprising: a base having a first channel in a top surface of the base;a lid having a second channel in a bottom surface of the lid; andwherein the lid is pivotably mounted to the base so as to be pivotablebetween: (i) an open position wherein the distal portion of theelongated housing can be laid into the first channel by movement in adirection substantially perpendicular to the longitudinal axis; and (ii)a closed position wherein the first and second channels form aheretically sealed cavity about the distal portion of the elongatedhousing.

The invention can, in even another aspect, be a system for measuring aphysiological condition within a mammal comprising: an apparatuscomprising: an elongated housing extending along a longitudinal axis; apH sensor for measuring pH within a body lumen of the mammal, the pHsensor located at a distal portion of the elongated housing; and aremovable cap for enclosing the distal portion of the elongate housing,the cap comprising: a base having a first channel in a top surface ofthe base; a lid having a second channel in a bottom surface of the lid;and wherein the lid is pivotably mounted to the base so as to bepivotable between: (i) an open position wherein the distal portion ofthe elongated housing can be laid into the first channel by movement ina direction substantially perpendicular to the longitudinal axis; and(ii) a closed position wherein the first and second channels form aheretically sealed cavity about the distal portion of the elongatedhousing.

In still another aspect, the invention can be a method of determiningfertility and/or vaginal health status in a female mammal comprising:inserting a probe into a vagina of the female mammal, a distal portionof the probe comprising an ISFET for measuring pH and a temperaturesensor for measuring temperature, the probe comprising a memory devicestoring parametric data unique to the pH sensor; measuring pH andtemperature with the ISFET and the temperature sensor of the probe;transmitting signals indicative of the measured pH and temperature to amicroprocessor; the microprocessor generating an output signalindicative of the fertility and/or vaginal health status in the femalemammal based on the signals indicative of the measured pH andtemperature and the parametric data; and displaying the output signal ona display device of the probe.

In a further aspect, the invention can be a method of determiningfertility and/or vaginal health status in a female mammal comprising:inserting a probe into a vagina of the, a distal portion of the probecomprising a pH sensor for measuring pH and a temperature sensor formeasuring temperature, the probe comprising a first memory devicestoring parametric data unique to the pH sensor; measuring pH andtemperature with the pH sensor and the temperature sensor of the probe;transmitting signals indicative of the measured pH and temperature to alogic controller; the logic controller generating an output signalindicative of the fertility and/or vaginal health status in the femalemammal based on the signals indicative of the measured pH andtemperature and the parametric data; and communicating the output signalto a user.

In an even further aspect, the invention can be a method of determiningfertility and/or vaginal health status in a female mammal comprising:inserting a probe into a vagina of the female mammal, a distal portionof the probe comprising an ISFET for measuring pH and a temperaturesensor for measuring temperature; measuring pH and temperature with theISFET and the temperature sensor of the probe; transmitting signalsindicative of the measured pH and temperature to a microprocessor; themicroprocessor generating an output signal indicative of the fertilityand/or vaginal health status in the female mammal based on the signalsindicative of the measured pH and temperature; and communicating theoutput signal to a user.

The invention may, in yet another aspect, be a method of determiningfertility and/or vaginal health status in a female mammal comprising:providing an apparatus comprising: an elongated probe housing a firstcircuit board operably coupling a pH sensor, a temperature sensor, and afirst interface connector located at a proximal portion of the probe;and a handle for manipulating the elongate probe, the handle housing asecond circuit board operably coupling a microprocessor, an indiciadevice, and a second interface connector; connecting the elongated probeto the handle so that the first and second interface connectors are inelectrical connection; inserting the elongated probe into a vagina ofthe female mammal; measuring pH and temperature with the pH sensor andthe temperature sensor of the probe; transmitting signals indicative ofthe measured pH and temperature to the microprocessor; themicroprocessor generating an output signal indicative of the fertilityand/or vaginal health status in the female mammal based on the signalsindicative of the measured pH and temperature and the parametric data;and communicating the output signal to a user via the indicia device.

In still another aspect, the invention can be a method of calibrating anapparatus for taking in vivo pH measurements comprising: a) providing aprobe having an elongated housing extending along a longitudinal axis, awell formed in a top edge of the elongate housing for holding fluids, apH sensor located on a floor of the well, the well located at a distalportion of the elongated housing; b) positioning the distal portion ofthe elongated housing on a base of a removable cap, the removable caphaving a lid in an open position; c) supplying a liquid buffered to aknown pH to the well and in contact with the pH sensor; d) moving thelid of the removable cap to a closed position so that the distal portionof the elongated housing is enclosed in a cavity of the removable cap,the cavity being substantially free of visible light; and e) calibratingthe pH sensor to the known pH.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a vaginal health apparatus according toan embodiment of the present invention, wherein the probe has beendisassembled from the handle.

FIG. 2 is a high level electrical schematic for the probe of the vaginalhealth apparatus of FIG. 1.

FIG. 3 is high level electrical schematic for the handle of the vaginalhealth apparatus of FIG. 1.

FIG. 4 is a top view of the probe of the vaginal health apparatus ofFIG. 1.

FIG. 5 is a cross-sectional view of the probe of FIG. 4 taken along viewV-V.

FIG. 6 is an exploded view of the probe of FIG. 4.

FIG. 7 is a close-up top view of the distal portion of the probe of FIG.4.

FIG. 8 is a cross-sectional view of the distal portion of the probetaken along view VIII-VIII of FIG. 7.

FIG. 9 is a top view of the vaginal health apparatus of FIG. 1 in anassembled state.

FIG. 10 is a cross-sectional view of the vaginal health apparatus alongview X-X of FIG. 9.

FIG. 11 is a close-up view of area XI of FIG. 10.

FIG. 12A is a perspective view of a removable cap according to oneembodiment of the present invention, the removable cap being in an openposition.

FIG. 12B is a perspective view of a vaginal health system according toone embodiment of the present invention including the vaginal healthapparatus of FIG. 1 and the removable cap of FIG. 12A.

FIG. 13A is a schematic of the vaginal health apparatus of FIG. 1inserted into the vagina of a humane female and positioned for vaginalpH and temperature measurements.

FIG. 13B is a schematic of the vaginal health apparatus of FIG. 1inserted into the vagina of a humane female and positioned for cervicalpH and temperature measurements.

FIG. 14 is a graph of in vivo pH measurement versus time for a humanfemale subject over a six day period wherein readings were taken everyten seconds over a two minute period.

FIG. 15 is a data chart and corresponding graph of pH measurementsversus voltage of three different pH buffers based on sample size sothat effects of the well size on pH readings could be evaluated.

FIG. 16 is a graph of measured pII versus time for urine over a four dayperiod wherein the urine was externally measured in the sample well.

FIG. 17 is a four day trend line graph of the final urine pHmeasurements of FIG. 16.

DETAILED DESCRIPTION OF THE INVENTION

One or more embodiments of the present invention will be discussed inthis section with reference to FIGS. 1-17. The embodiments illustratedherein are not intended to be exclusive or to limit the invention to theprecise form or application disclosed. The embodiments are chosen anddescribed merely to explain one or more desired embodiment of thestructure, use and/or application of the invention. While the inventionis specifically described below as a “vaginal health device,” theinvention is not limited to this application or to the exact structureexemplified. The present invention can be used to determine anyphysiological condition of a mammal that can be determined by pH and/ortemperature values and/or variations thereof over a period of time. Theinvention can be used to determine any physiological condition, such asfertility, vaginal health, oral health, gastro-intestinal health,dietary health, etc. Specific examples of physiological conditionswithin the scope of this invention include without limitation ovulation,menopause, acidosis, diabetes, diarrhea, starvation and dehydration,respiratory disease, urinary tract obstruction, pyloric obstruction,salicylate intoxication, renal tubular acidosis, chronic renal failure,BV, candidiasis and trichomoniasis Moreover, the present invention canbe used to measure the pH and/or temperature of biological fluids bothexternally and in vivo. For external measurements, the sample wellallows for the accurate measurement of pH and/or temperature for bodilyfluids such as saliva, urine and blood. For in vivo measurements, theinvention can also take pH and/or temperature measurements in anydesired body lumen, including without limitation the vagina, cervix,esophagus, mouth, nasal passages, auditory canals, digestive tract,urethra, and vascular system.

The invention is generally described in relation to the human female.However, the inventive principals can be applied in veterinaryapplications with a simple modification of the size (length anddiameter) and/or shape of the structure to fit various mammals includingdogs, cats, dairy cows and horses. As a result, veterinary applicationsfor monitoring vaginal pH, cervical pH, oral pH or urinary pH can beaccomplished for diagnosis and determination of a physiologicalcondition in the art of veterinary medicine.

The invention allows for measurement of the pH and/or temperature ofbiological fluids in a private (i.e., in the home) or clinical labenvironment. As will be discussed in detail below, the invention allowsfor easy change, updating and/or replacing of the probe of the apparatusto keep up with latest technologies in measuring pH. For example, insome embodiments of the invention, the pH sensor may be a reference FET(REFET) which could be implemented with an ISFET and a pseudo referenceelectrode. In such a design, the electrode wire (which is typically anAg/AgCL coated wire) and electrolyte solution may be eliminated.

Additionally, the incorporation of the vital product data (VPD) into amemory device within the probe of the apparatus allows the probe to beeasily interchanged with other logic assemblies without the need forextensive two point calibration. The incorporation of the VPDinformation within the probe itself simplifies user operation as keyinformation about the probe characteristics and use are stored withinthe memory device of the probe itself. The logic assembly (which acts asthe handle) can easily read this information in order to guide the userthrough proper operation, whether it is taking measurements orcalibration. The ability to store and retrieve important calibration andother information within the probe make the invention a “plug-and-play”type of device.

Referring now to FIGS. 1 and 9, a vaginal health apparatus 100 isillustrated according to one embodiment of the present invention. Thevaginal health apparatus 100 generally comprises a probe component 200(sometimes referred to as the “probe”) and a handle component (sometimesreferred to as the “handle). The vaginal health apparatus 100 isillustrated in FIG. 1 in a disassembled state wherein the probe 200 hasbeen disconnected from the handle 300. In FIG. 9, the vaginal healthapparatus 100 is illustrated in an assembled state wherein the probe 200is connected to the handle 300.

The general structure and shape of the probe 200 is formed by itselongated housing 201, which in the illustrated embodiment, has anelongated linear rod-like shape. The elongated housing 201 extends froma proximal end 202 to a distal end 203 along a longitudinal axis A-A(FIG. 4). The elongated housing 201 is a tubular structure that isspecifically sized and shaped for insertion into the human vagina sothat pH and/or temperature measurements can be taken either in thevaginal tract or at the cervix. Of course, other elongated shapes can beutilized, including curved rods.

The elongated housing 201 has a substantially circular transversecross-sectional profile. Of course, the elongated tubular housing 201can have a transverse cross-sectional profile of various shapes andsizes. The exact size and shape of the elongated housing 201 will bedictated by the end use to which the vaginal health apparatus 100 is tobe put, and is not to be considered limiting of the present inventionunless specifically recited in the claims.

Conceptually, the elongated housing 201 comprises a proximal potion 210,a middle portion 220 and a distal portion 230. A fluid sample well 240is formed in the distal portion 230 of the probe 200. The well 240 actsas a reservoir for holding biological fluids, such as urine, saliva,blood, cervical fluids, vaginal fluids and/or other bodily fluids. A pHsensor 250, a temperature sensor 260 and a diaphragm 270 are locatedwithin the well 240.

Turning to the handle, the general structure and shape of the handle 300is formed by its box-like housing 301, which in the illustratedembodiment, comprises a tapered portion 310 and a generally rectangularbox portion 320. The handle housing 301 provides a means by which theuser can manipulate the movement of the probe 200 within the desiredbody lumen (when assembled as discussed below). The handle housing 301comprises a top surface 302, a bottom surface 303, and a plurality oflateral surfaces 304 that bound the top and bottom surfaces 302, 303,thereby forming a substantially closed and hollow structure. The handle300 generally comprises a display device 330, user controls 340-342, afirst data port 314 and a second data port 315 (these elements will bediscussed in greater detail below).

When the vaginal health apparatus 100 is assembled (as shown in FIG. 9),the probe 200 is removably (i.e., non-fixedly) secured to the handle300. In other words, the probe 200 and the handle 300 are connected in amanner that allows the probe 200 and the handle 300 to be repetitivelyconnected and disconnected without compromising the structural orfunctional integrity of either the probe 200 or the handle 300. In theillustrated embodiment, the probe 200 is removably secured to the handle300 by slidably inserting the proximal portion 210 of the elongatehousing 201 into a socket 519 (visible in FIG. 11) formed into thetapered portion 310 of the handle housing 301. The socket 519 of thehandle housing 301 and the proximal portion 210 of the elongated housing201 are correspondingly sized and shaped (relative to one another) sothat a tight fit exists between the proximal portion 210 of the elongatehousing 201 and the walls of the socket 519 of the handle housing 301when the proximal portion 210 is fully inserted within the socket 519.This tight fit assembly provides adequate structural connectivitybetween the handle 300 and the probe 200 so that the probe 200 does notseparate (or otherwise become dislodged) from the handle 300 during use.The proximal portion 210 of the elongated housing 201 has a taperedtransverse cross-sectional area that helps facilitate slidable insertioninto the socket 519 of the handle housing 301 and increases frictionalengagement with the walls 521 (FIG. 11) of the socket 519.

While the non-fixed connection between the probe 200 and the handle 300is exemplified as a tight-fit assembly, other mechanisms and structuralarrangements can be implemented to effectuate the desired connection,either in addition to or in replace of the tight-fit technique. Forexample, one or more depressions could be provided in either theproximal portion 210 of elongated housing 201 or the walls 521 of thesocket 519 of the handle housing 301 that snap-fit (or otherwise mate)with tangs (or some other protuberance) provided on the other one of theproximal portion 210 of elongated housing 201 or the walls 521 of thesocket 519 of the handle housing 301. Alternatively, the outer surfaceof the proximal portion 210 of the elongate housing 201 and the walls521 of the socket 519 of the handle housing 301 can be provided withcorresponding threads for threaded engagement. In other embodiments, abayonet lock, magnets, cotter pins, or combinations of theaforementioned techniques could be implemented.

A slot 211 is formed into the proximal portion 210 of the elongatehousing 210 of the probe 200. The slot 211 is a linear slot that extendsfrom the proximal end 202 toward the distal end 203 of the elongatedhousing 201 along a top edge of the elongated housing 201. The slot 211is provided on the elongated housing 201 to ensure proper rotationalorientation of the elongated housing 201 when the probe 200 is connectedto the handle 300. A key or other protuberance 522 (FIG. 11) is providedon the wall 521 of the socket 519 of the handle housing 301. When theprobe 200 is in the proper rotational orientation during assembly, thekey 522 mates with the slot 211, allowing the proximal portion 210 toenter the socket. However, if the probe 200 is in an improper rotationalorientation during assembly, the key 522 prohibits the proximal portion210 from entering the socket. An indicia marker 311 on tie top surface302 of the handle housing 301 indicates the circumferential position ofthe key 522 (or protuberance) within the socket 519. The key/slotassembly also prevents undesired rotation of the probe 200 with respectto the handle 300 once assembly of the vaginal health apparatus 100 isachieved. As will be discussed below, proper rotational orientation ofthe probe 200 with respect to the handle 300 during and after assemblyis important to ensure proper and stable electrical connection betweenthe separate circuit boards of the probe 200 and the handle 300.

The probe 200 can be removed for the handle 300 for easy cleaning withwarm water or mild soapy water and then rinsed with warm water. In aclinical environment, the probe 200 would need to be sterilized withsomething similar to CIDEX OPA solution (Johnson and Johnson).Alternately, the probe 200 could be designed with material such as PEEKand be subjected to autoclaving temperatures of about 130° C. For theillustrated embodiment, the use of non-autoclaving process is suggested.The probe 200 in this embodiment is approximately 0.40 inches indiameter and 7 inches long. Changes in dimensions can be accommodated inorder to support pH measurement in other female mammals.

As will be discussed immediately below, the circuitry to be positionedwithin the probe 200 and the circuitry to be positioned within thehandle 300 is strategically selected so that: (1) the probe 200 is asinexpensive as possible so that it can be discarded and replaced asnecessary; (2) the handle 300 can be used in conjunction with differentprobes 200 and still prove accurate and reliable measurements; (3) alldata relating to the measurements taken over periods of time is storedwithin the handle 300 for either internal or external processing; and/or(4) the need for calibration is minimized. As a result of this strategicseparation and placement of circuitry, the handle 300 becomes the logiccontroller assembly of the vaginal health apparatus 100.

Referring to FIGS. 2-3 concurrently, the strategic separation andselection of the circuitry necessary to run the vaginal health apparatus100 is shown according to one embodiment of the present invention. FIG.2 is a high level electrical schematic of the circuit 400 which islocated within the elongated housing 201 of the probe 200. FIG. 3 is ahigh level electrical schematic of the circuit 500 which is locatedwithin the housing 301 of the handle 300.

With reference to FIG. 2, the primary components of the circuit locatedwithin the probe 200 are the pH sensor 250, an analog interface circuit416, a reference electrode 421, the temperature sensor 260, thediaphragm 270, KCL solution 422, a non-volatile memory 415 and aninterface connector 417. All of these components are operably coupledvia a circuit board, which is located within the elongated housing 201,as is well known in the art.

The pH sensor 250 is preferably an ISFET, which is a semiconductordevice which has the metal gate replaced with a hydrogen-ion sensitivelayer. The ISFET 250 is the primary element in measuring the hydrogenion concentration (i.e., the pH) of the biological fluid to be measuredwith the vaginal health apparatus 100. When the hydrogen ions contactthe gate sensitive layer of the ISFET 250, the voltage between the gateand source of the ISFET is influenced. The reference electrode 421 isrequired to close the electrical circuit loop. The analog circuitry 416drives the electrode 421 in order to maintain a constant current throughthe drain and source of the ISFET 250. It is this drive voltage changethat is used as the pH output signal and used by the A/D converter 502(which located on the circuit 500 within the handle 300) to measure pHof the biological fluid under examination. The reference electrode 421is preferably a typical Ag/AgCL coated wire and is placed in the KCLsolution 422. The diaphragm 270 is the conduit between the KCL solution422 and the biological fluid being measured. While the pH sensor ispreferably an ISFET, in some embodiments of the invention the pH sensorcan be a combination of ISFET and REFET (Reference FET) with a PseudoReference Electrode. As technology improves for the creation of theREFET, it would be easy to replace the combination of the ISFET andstandard Reference Electrode comprised of the reference electrode 421and KCL solution 422. For example the ISFET and REFET could be producedon the same substrate with a platinum electrode which may consist simpleof an evaporated layer of Pt deposited on the ISFET/REFET substrate. Itis also possible for a totally solid-state sensing probe to beincorporated into the invention.

The temperature sensor is preferably a thermistor, and more preferably atypical NTC (negative temperature coefficient) device. While thetemperature sensor is preferably a thermistor, in some embodiments ofthe invention the temperature sensor can be a thermocouple or infrareddetector.

The non-volatile memory 415 is preferably a simple 2 wire serial memorythat can be read by and written to by the microprocessor 510 (which islocated on the circuit 500 of the handle 200). The interface connector417 is preferably one or more PCB pads. The invention, however, it solimited and any suitable mechanism, technique or device that can be usedto repetitively engage and disengage with a corresponding interfaceconnector to operably and electrically couple circuits together can beused. For example, the interface connector 417 could be multi-pinconnector, a USB connector, a firewire connector, or other jack or pinand socket combination.

Referring now to FIG. 3, the primary components of the circuit 500located within the handle 300 are the microprocessor 510, A/D converter502, the display device 330, control switches 340-342, the first andsecond data ports 314, 315, an interface connector 517, a DC/DCconverter 515, an audible device 516, and a battery 520. All of thesecomponents are operably coupled via a circuit board, which is locatedwithin the handle housing 301, as is well known in the art.

The control switches 340-342 are used to select various functions of thevaginal health apparatus 100, such as power on/off, calibration,start/stop measurements, etc. These functions can be displayed via menuscreens on the display device 330. The display device 330 is preferablyan LCD display panel, such as a full graphic display or a simplesegmented and icon based display. However, the display device 330 can beany type of device used to visibly display information or status, suchas one or more LEDs, OLED display, or other types of screens, such asplasma or LED.

The first and second data ports 314, 315 can be any type of wired orwireless port that can facilitate data transfer and communicationbetween the vaginal health apparatus 100 and an external electronicdevice, such as a computer, cell phone, handheld data assistant, or thelike. Examples of data ports include without limitation firewire ports,USB ports, miniUSB ports, IRDA ports, serial ports (such as RS232),multi-pin ports, RF transceivers, etc.

The interface connector 517 is preferably one or more compressionconnectors for operably and electrically coupling with the interfaceconnector 417 of the circuit 400 of the probe 200. As discussed above,the interface connector 517 is selected to mate with the type ofinterface connector 416 chosen for the probe 200. Any of the types ofconnectors mentioned above for the interface connector 417 can be usedfor the interface connector 517 of the circuit 500 of the handle 300.

The interface connectors 417, 517 are selected and positioned within theprobe 200 and handle 300 respectively so that when the probe 200 isassembled/connected to the handle 300 (as described above), theinterface connectors 417, 517 come into and stay in operable connectionwith one another so that data signals and power can be transmittedbetween the two circuits 400, 500. When the interface connectors 417,517 are in operable connection, the power source 520, which ispreferably in the form of a lithium coin cell battery, provides thenecessary power for both of the circuits 400, 500. Additionally, pH andtemperature signals generated by the pH and temperature sensors 250, 260are transmitted to the microprocessor 510 (after passing through the A/Dconverter 502) for processing and or storage. Additionally, themicroprocessor 510 can access and retrieve data (such as parametricdata, such as properties and parametric data, that is inherent to the pHsensor 250), stored in the memory device 415 of the circuit 400.

Referring now to FIGS. 4-6 concurrently, additional details of the probe200 will be discussed. As discussed above, the probe 200 comprises anelongated housing 201 which extends from a proximal end 202 to a distalend 203 along the longitudinal axis A-A. The elongated housing 201comprises a main housing portion 204, a cover 205 and a coupling 206.Preferably, the elongated housing 201 is constructed of a plastic, suchas a medical grade ABS material, or other biocompatible material.

The coupling 206 forms the proximal portion 210 of the elongated housing201 while the cap 205 extends along the distal portion 230 of theelongated housing 201. The coupling 206 comprises four spaced apartflexible tabs 207 extending from its distal edge for insertion into theinternal chamber(s) 221, 222 of the main housing portion 204. When theprobe 200 is assembled, the flexible tabs 207 of the coupling 206 areslid into the internal chamber(s) 221, 222 of the main housing portion204 until a collar 208 of the coupling 206 contacts the proximal edge ofthe main housing portion 204. Frictional contact between the tabs 207and the inner surface of the main body portion 204 secure the coupling206 to the main body portion 204. The connection between the coupling206 and the main body portion 204 can be further enhanced by using anadhesive, sonic weld, thermal weld, or any other connection techniquesthat are now known or later developed in the art. Preferably, theinterface between the coupling 206 and the main housing portion 204 ishermetic so that fluids can not enter the elongate housing 201 at thislocation.

The lower longitudinal section 209 of the coupling 206 is solid whilethe upper longitudinal section comprises a cavity 212 that extends theentire length of the coupling 206, thereby forming a longitudinalpassageway through the coupling 206. The cavity 212 is in spatialcommunication with the slot 211 (which was discussed above in detail).When the coupling 206 is secured to the main body portion 204 when theprobe 200 is assembled, the cavity 212 of the coupling is in spatialcommunication with the top chamber 221 of the main body portion 204. Asexplained in greater detail below, this allows the circuit board 280(the majority of which is housed in the upper chamber 221 of the mainhousing portion 204) to extend into the cavity 212 of the coupling 206.

As discussed above, the transverse cross-sectional profile of thecoupling 206 is tapered along its longitudinal length, with the smallestarea being at the proximal end 202. This allows the coupling 206 to beinserted into the socket 519 of the handle housing 300.

The main housing portion 204 comprises an outer tubular wall 213 thatforms an elongated internal cavity. A transverse wall 214 that extendsalong the longitudinal axis A-A is provided within (and integrallyformed with) the outer tubular wall 213, thereby separating theelongated internal cavity into a first longitudinal chamber 221 and asecond longitudinal chamber 222. The first and second longitudinalchambers 221, 222 extend in an axial adjacent manner and arehermetically isolated from one another. The transverse wall 214 ispreferably centrally arranged within the outer tubular wall 213 but canbe offset from the longitudinal axis if desired. The transverse wall 214is preferably a flat wall having planar upper and lower surfaces. Theinvention, however, is not so limited and the transverse wall can takeon other shapes and contours if desired.

A par-cylindrical cutout 215 is provided at the distal portion 230 ofthe main housing portion 204, thereby exposing a portion 216 of thetransverse wall 214 and creating an open end for the upper chamber 221.While the “missing portion” of the main housing portion 204 is describedas a “cutout,” it is not necessary for the opening to be the result ofsome type of cutting, punching or breaking process. It is intended thatthe term “cutout” merely mean an opening, which, for example, may resultfrom the main housing portion 204 being formed in the illustrated shapeduring an injection molding process. Additionally, the exact shape andlocation of the cutout 215 can vary as desired.

A plurality of protuberances 217 (in the form of pins) project upwardfrom the upper surface 232 of the exposed portion 216 of the transversewall 214. The protuberances 217 are provided to mate with correspondingbores in the cap 205 to ensure proper alignment between the cap 205 andthe main housing portion 204 during assembly of the probe 200. Aretaining structure 218, in the form of an upstanding U-shaped wall,also projects upward from the upper surface 232 of the exposed portion216 of the transverse wall 214. The retaining structure 218 and some ofthe protuberances 217 retain and align the circuit board 280 in itsproper position within the upper chamber 221 when the probe 200 isassembled.

A hole/opening 219 is provided on the exposed portion 216 of thetransverse wall 214 that forms a passageway through the transverse wallinto the lower chamber 222 of the elongated housing 201. The holes is219 is sized and shaped to accommodate the diaphragm 270 so that a firstportion of the diaphragm 270 is exposed to the biological fluid beingtested while a second potion of the diaphragm 270 protrudes into thelower chamber 222 and is in contact with the KCL solution 422.

The cover 205 is a par-cylindrical structure that is sized and shaped tocorrespond to the cutout 215 so that the cover 205 can enclose thecutout 215 when the probe 200 is assembled. The connection of the cover205 to the main housing portion 204 will be described below in greaterdetail with reference to FIGS. 7-8. The cover 205 generally comprises anouter surface 225. The well 240 is formed into the outer surface 225 ofthe cover 205.

The cover 205 comprises three holes/openings 226-228 (which are locatedon a floor 241 of the well 240) that provide passageways through thecover 205. The opening 226 is sized and shaped to accommodate thediaphragm 270 so that it is exposed to biological fluids during use viathe opening 226. The opening 227 is sized and shaped to accommodate thepH sensor/ISFET 250 so that it is exposed to biological fluids duringuse via the opening 227. The opening 228 is sized and shaped toaccommodate the temperature sensor 260 so that it is exposed tobiological fluids during use via the opening 228. The walls 229 of theopening 227 are tapered to help funnel and direct the biological fluidsinto contact with the ISFET 250. The walls 231 of the opening 228 arealso tapered to help funnel and direct the biological fluids intocontact with the temperature sensor 260.

The ISFET 250, the temperature sensor 260, the non-volatile memory chip415, the reference electrode 421 and the interface connector 416 are allmounted on the small printed circuit board 280. The ISFET 250 istypically mounted to the printed circuit board 280 via epoxy and wirebonds although other mounting techniques, such as compressionconnections, are possible. As will be discussed in greater detail below,only a portion of the ISFET 250 contains the hydrogen ion sensingportion which makes contact with the test liquid or material via theopening 227.

The non-volatile memory chip 415, which is also located on the printedcircuit board 280, is utilized to store various data. Generally, thedata stored in this memory 415 is referred to herein as Vital ProductData (VPD). The VPD information contains information such as probeserial number, probe manufacturer, calibration information, parametricdata unique to the ISFET and temperature sensor being used, and timesince last calibration. The VPD information is intended to be used bythe microprocessing unit 510 in the handle housing 300. The processingunit 510 will always read the contents of the memory device 415 toidentify the VPD information in order to determine what if any actionsmight be required by the user before measurement.

For example, in one embodiment of the invention, the VPD informationstored in the memory device 415 of the probe 200 includes:

-   -   1) Serial # information (fields 00-09). This contains important        information regarding build date and location.    -   2) Vendor Name (fields 10-24)    -   3) Assembly # (fields 25-2E)    -   4) 3 point calibration information at ambient (room temperature)        (fields 30-37 in VPD_details)    -   5) 3 point calibration information at body temperature (98.6 F.        or 37 C.). (fields 38-3F in VPD_details)    -   6) Date Last Calibrated (fields 60-65 in VPD_details)    -   7) Number of Measurements Since Last Calibration (fields 66-67        in VPD_details)    -   8) Number of pH measurements Taken (fields 68-6A in VPD_details)    -   9) ISFET Leakage (fields 46-47)    -   10) ISFET Lot # (fields 48-4F)

Storing the “Date Last Calibrated” in the memory device 415 allows themicroprocessor 510 to force the user to follow proper operatingprocedures in order to maximize accurate measurements. For example if itis determined that the vaginal health apparatus 100 has not beencalibrated for an extended period of time, say 30 days, the firmwarewould not allow the user to take a vaginal measurement until pH7 buffercalibration in the sample well 240 is completed.

Storing the “Number of Measurements Since Last Calibration” in thememory device 415 ensures proper calibration in the event that, even ifthe vaginal health apparatus 100 was calibrated within a specific timeframe, but was used say 10 times without calibration, the microprocessor510 would then force the user to calibrate to maintain accuracy. Forexample in a doctor's office or other clinical environment, if they usedit 10 times in one day the microprocessor 510 would force the doctor todo a calibration procedure to make sure accurate measurements are taken.

Storing the “Number of pH Measurements Taken” in the memory device 415ensures that the useful end of life of the product can be monitored. Forexample if it is determined that drift occurs within the vaginal healthapparatus 100 (say the KCL electrolyte solution ages or gets slightlycontaminated) after 2000 measurements, the vaginal health apparatus 100can automatically notify the user that the probe 200 needs to bereplaced with a new one.

By storing calibration information at room and ambient temperature inthe memory device 415, more accurate pH measurements can be attained byutilizing the unique temperature characteristics of the ISFET 250. Thetemperature correction factor can be obtained by calculating differencesin slope or absolute values. For example if the readings at 98.6° F.vary by 0.1 pH versus the readings at ambient (say 70° F.) then themicroprocessor 510 can compensate for these readings when vaginalmeasurements are taken. So, if a user does an occasional pH7buffercalibration in the sample well 240, the microprocessor 510 would be ableto determine the ‘correction factor’ for a measurement at 98.6° F.Correction for tolerances associated with the thermistor 260 and seriesresistor can be automatically compensated for as the absolute value at98.6° F. is stored during the manufacturing test and calibrationprocess.

Storing the VPD information in the memory device 415 within the probe200 allows for “plug and play” operation by the end user, therebysimplifying operation and making this a user friendly product. Thestorage of the VPD information in the memory device 415 within the probe200 is also important to minimize the number and level of calibrationcycles required. Inclusion of parametric data that is unique to thespecific ISFET 250 and thermistor 260 being used is an important factorin reducing and simplifying the amount of required user interaction andcalibration. For example, the processing unit 510 may read the fieldindicating that the probe was not calibrated for an extended period oftime and would automatically force the user to run a single pointcalibration to insure proper measurement results.

As set forth and exemplified above, the VPD information containsparametric data unique to the characteristics of the particular ISFETand thermistor housed within that probe assembly. The ability to storethis unique parametric data enables the firmware within the handlehousing 300 to read specific data which enables more accuratemeasurements and simplifies user operation. The ISFET is a semiconductordevice similar to a MOSFET. As such it has characteristic curves forcurrent and voltage. The desired mode of operation for the ISFET is in aconstant drain to source voltage (V_(ds)) and constant drain to sourcecurrent (I_(ds)). As the characteristics curves of the ISFET changeslightly from ISFET to ISFET, the absolute voltage values will change aswell when implemented in the circuit. ISFETs are built on silicon wafersand thus, the parametric properties of each ISFET will vary from lot tolot and, in some instances, even vary from wafer to wafer or device todevice (even if on the same wafer). Such differences are due totolerances and inherent variations in the manufacturing process. Thesedifferences result in slight variables in ISFET characteristic such asISFET leakage current, drain-source voltage/current curves, capacitance,etc. As stated earlier, the gate portion of the ISFET is replaced withan ion sensitive layer which can consist of material such as Si₃N₄,Al₂O₃ or TA₂O₅. Variations in the ion sensitive layer will alsocontribute to the characteristics of the ISFET. The combination of theseISFET characteristics along with temperature determines the slope andabsolute voltage for a given pH. Thus, one ISFET placed in the circuitmay exhibit a slope voltage per pH characteristic of say 55 mv/pH whileanother ISFET may produce a slope characteristic of 54 mv/pH. Inaddition, the absolute voltage value generated by the circuitry for aparticular ISFET placed in a fixed buffer solution will vary amongISFETs. It is these variances and others that effect the parametrics ofthe ISFET/probe combination that require memorization and are stored inthe VPD within the probe assembly.

All of these unique characteristics add up to make each and every ISFET250 slightly unique, even when from the same wafer. Thus, when the ISFET250 is put into the circuit 400 in the factory, the slope of each ISFET250 and the absolute voltage value for a particular pH value will bedifferent.

Also how the ISFET 250 drifts with time due to leakage current will bedifferent since the leakage current of each device will be unique. Inthe case of ISFETs, variables also exist regarding the gate membranematerial application which will certainly have an effect as well. EachISFET will also have unique characteristics regarding drift withtemperature. So, by storing the parametric data that is unique to theexact ISFET 250 being used in the completed probe 200, the vaginalhealth apparatus 100 can compensate for as many variables as possiblethat effect the readings. Because the probe 200 also includes otherelectronics, such as the op amp, the voltage reference, the Ag/AgCLelectrode and electrolyte solution (which complete the ISFET circuit),the ISFET 250 is essentially profiled along with all the othercomponents that complete the probe 200.

The following are examples of parametric data unique to the ISFET 250(and the assembled combination of electrode 421, KCL electrolyte 422solution and diaphragm 270) that are stored in the memory device 415:

ISFET xpH Factory Value Low Temp:

This is the value measured and programmed during final production test.These values are used to determine the ISFET slope. These values areonly programmed at the factory during final testing. They will howeverbe read by the software within the handle 300 to determine ISFET slope.The value programmed in this field should reflect the ambienttemperature (25 C.).

Low Temperature Value:

This is the temperature value measured during the ISFET xpH Factory LowTemperature value calibration cycle. It is written the same time as theISFET xpH Factory Value Low Temp fields are written. This temperatureshould be approximately 25 C.

ISFET xpH Factory Value High Temp:

This is the value measured and programmed during final production test.These values are used to determine the ISFET slope. These values areonly programmed at the factory during final testing. They will howeverbe read by the software within the handle 300 to determine ISFET slope.The value programmed in this field should reflect the high temperaturevalue of 39 C.+/−0.1 C. (98.6 F. +/−0.2 F.).

High Temperature Value:

This is the temperature value measured during the ISFET xpH Factory HighTemperature value calibration cycle. It is written the same time as theISFET xpH Factory Value High Temp fields are written. This temperatureshould be 39 C.+/−0.1 C. (98.6 F +/−0.2 F.).

ISFET Temp Correction Value:

This is a place holder for any information that might be required forcorrection of pH Value with temperature. It is assumed that the ISFETxpH Factory Value will be calculated and programmed while at 25° C. TheCorrection Value should be for measurement at 37° C. or if correction islinear the correction required per 1° C.

ISFET Leakage Current:

This is a value in stored in uA so that it can be used to possibledetermine ISFET drift over time and used by software to possiblecompensate for this.

Referring still to FIGS. 4-6, the circuit board 280 is of an elongatedshape and is positioned within the upper chamber 221. More specifically,the circuit board 280 is positioned within the upper chamber 280 andsecured to the upper surface 232 of the transverse wall 214. The circuitboard 280 is held in place against the transverse wall 214 via a keyingsystem in order to make sure that the ISFET 250 and temperature sensor260 are properly aligned with the openings 227, 228 of the cover 205when the cover 205 is secured to the main housing portion 204 to enclose(and seal) the cutout 205.

A proximal portion 281 of the circuit board 280 extends into the cavity212 of the coupling 206. The proximal portion 281 of the circuit board280 comprises the interface connector 417, in the form of PCB pads,which are located on the bottom surface of the circuit board 280 foroperable contact/mating with the interface connector 517 of the handlehousing 300 when the vaginal health apparatus 100 is assembled.

While the circuit board 280 is located within the upper chamber 221, thereference electrode 421 extends from the circuit board 280 and into thelower chamber 222. The lower chamber 222 is filled with an electrolytesolution 422 that is buffered at a known pH, such as KCL at a pH of 7.0.The lower chamber 222 is hermetically sealed in order to prevent anyleakage of the electrolyte solution 422. The sealing of the open end ofthe lower chamber 222 is accomplished using an electrolyte plug 233. Thereference electrode 421 extends through a small hole 234 in the plug233. The appropriate hermetic seal is then formed with an appropriateepoxy or ultrasonic or thermal welding.

Referring now to FIGS. 7-8 concurrently, the construction of the distalportion 230 of the probe 200, and the relationship between itscomponents, will be described in greater detail. As discussed above, thecover 205 of the probe 200 comprises a well 240 that acts as a reservoirfor holding a biological fluid that is to be measured with the vaginalhealth apparatus 100. The well 240 is a depression, channel or grooveformed into a top edge of the cover 205 that acts as a reservoir (orsmall bowl) for biological fluids. In addition, the well 240 provides amethod for taking in-vitro measurements. Sample material or swabs can betaken and placed into the sample well 240 if desired.

The sample well 240 also provides a method for easy calibration and areduction of the amount of calibration solution required. Only a smallvolume of buffer solution (a few drops) will be required for thecalibration process. Of course, the well 240 can be modified toaccommodate more or less material by easily modifying the length, widthor depth of the depression.

The well 240 comprises a floor 241 and an annular rim 242 that surroundsthe floor 241. The annular rim 242 provides an upstanding wall thatretains the biological fluid within the well 240. The well 240 isdesigned into the probe 200 so that it can be easily inserted into thevagina for in-vivo measurement of the vaginal wall surface or theectocervix. During such use, the annular rim 242 can be scraped againstthe vaginal wall or cervix by rotating the probe 200 so as to forcefluids into the well 240.

The ISFET 250, the temperature sensor 260 and the diaphragm 270 areembedded within the floor 241 of the well 240 in order to provide anaccurate pH measurement. The ISFET 250, the temperature sensor 260 andthe diaphragm 270 are exposed to the exterior of the apparatus 100 viathe openings 226-228, which are aligned along an axis that is spacedfrom and substantially parallel to the longitudinal axis A-A. Aligningthe openings 226-228 on such an axis ensures that the diaphragm 270,ISFET 250 and temperature sensor 260 all make contact with the samplematerial, allowing for an accurate pH measurement and/or temperaturemeasurement.

The wall 229 of the opening 227 that surrounds the ISFET 250 istapered/sloped to assist in capturing and directing the fluids and/ortissue in contact with the ISFET 250. Similarly, the wall 231 of theopening 228 that surrounds the temperature sensor 260 is alsotapered/sloped to assist in capturing and directing the fluids and/ortissue in contact with the temperature sensor 260.

A fluid tight seal is required around the ISFET 250 and the temperaturesensor 260 in order to prevent contamination or leakage of fluids intothe electronics of the probe 200. However, both the ISFET 250 and thetemperature senor 260 need to remain exposed via the openings 227, 228in order to take accurate pH and temperature measurements.

The hermetic seal of the opening 27 about the ISFET 250 can beaccomplished by various means, such as an epoxy, O-ring or gasket seal.In the illustrated embodiment, a gasket 235 is compressed between thebottom surface of the cover 205 and the perimeter portion of the ISFET250. The gasket 235 can be held in place by the plastic cover 205 orcould be over molded onto the bottom surface of the cover 205.

The temperature sensor 260 preferably comprises a metal cap 261 that isplaced over and covers a thermistor 262. The metal cap 261 can beconstructed of a medical grade stainless steel or other metal which is agood thermal conductor. A small space/gap exists between the metal cap261 and the thermistor 262. The space/gap, in one embodiment, isapproximately 0.005 inches. This space/gap is filled with a material,such as an epoxy, having high thermal conductivity but that iselectrically non-conductive. Filling this gap/space with such a materialreduces the thermal time constant of taking a temperature measurement.In the illustrated embodiment, a surface mount thermistor is used.However, a typical bead thermistor can also be utilized and adhered tothe stainless steel cap 262.

The metal cap 261 keeps the thermal time constant as low as possible andshould have as small an area as practical with a thickness kept as thinas practical (0.10″ in this embodiment). The temperature sensor 260 isused for measuring the temperature of the vagina or cervix during the pHmeasurement. Although an exemplary application of the temperature sensor260 is detailed, those skilled in the art will appreciate that analternate temperature sensing device can be used, such as a thermocoupleor infrared detection. The temperature sensor 260 also providestemperature information used during the manufacturing process andcalibration in order to allow for proper thermal compensation of the pHreading.

As with the ISFET 250, it is necessary to create a fluid tight sealabout the opening 228 while leaving the metal cap 261 exposed to thebiological fluid/tissue to be tested via the opening 228. The hermeticseal of the opening 228 about the metal cap 261 can be accomplished byvarious means, such as an epoxy, O-ring or gasket seal. In theillustrated embodiment, a gasket 236 is compressed between the bottomsurface of the cover 205 and the top surface of the metal cap 261. Thegasket 236 can be held in place by the cover 205 or could be over moldedonto the bottom surface of the cover 205. The gasket 236 is compressedthe proper amount when the plastic cover 205 is secured to the mainhousing portion 204.

The gaskets 235, 236 are sufficiently compressed when the plastic cover205 is secured to the main housing portion 204. The cover 205 ispermanently secured to the main housing portion 204 so that the cutout215 is hermetically sealed, thereby sealing the distal portion of theupper chamber 221. The interface between the cover 205 and the mainhousing portion 204 can be sealed by epoxy, a sonic weld, a thermal weldor another compressed gasket.

The diaphragm 270 is positioned within and extends through the opening226 of the cover 205 and the opening/hole 219 in the transverse wall 214of the elongate housing 201. A first portion 271 of the diaphragm 270 isexposed to the biological fluid being measured via the opening 226 whilea second portion 272 of the diaphragm 270 extends into the lower chamber222 via the hole 219. The second portion 272 of the diaphragm 270 is incontact with the KCL solution 422 within the lower chamber 222 of theelongate housing 201. The walls 237 of the opening 226 extendtransversely (relative to the longitudinal axis) and contact thetransverse wall 214 so as to form a seal at the interface between thetwo, thereby keeping the upper chamber 221 (and the circuit board280)hermetically sealed from fluids and contamination.

The diaphragm 270 can be either a ceramic or PTFE material that iscommonly used in pH probe assemblies. The diaphragm 270 allows thehydrogen ion flow between the reference electrode 421 and the KCLsolution 422 and the measurement fluid. The diaphragm 270 provides theelectrical connection between the reference electrode 421 and thebiological fluid being measured.

Referring now to FIGS. 10-11 concurrently, the assembly of the probe 200to the handle 300, which also operably couples the measuring circuit 400to the logic circuit 500, will be discussed in greater detail. When theprobe 200 is assembled to the handle 300, the proximal portion 210(i.e., the coupling 206) of the probe 200 is inserted into the socket519 of the handle housing 301 as discussed above. The assembly of theprobe 200 to the handle 300 results in the operable connection of theprobe circuit 400 (FIG. 2) to the logic circuit 500 (FIG. 3) because thegold plated PCB pads 417 of the printed circuit board 280 of the probe200 come into operable and electrical connection with the compressionconnectors 517 of the printed circuit board 580 of the handle 300. Thegold plated PCB pads 417 are configured in a manner such that the Groundsignal pin, which is the return path for the supply voltage provided bythe housing 300, is slightly longer (about 0.020″) at the proximal 210end than the other gold plated PCB pads. The purpose of this extendedpad is so the first electrical connection made when inserting the probe200 into the housing 300 is the ground pin. This first “make” connectionhelps in providing a discharge path for any erroneous charges that maybe residing in the probe 200 or housing 300 assemblies. The otherfunction of this elongated pin is to provide the last connection whendisengaging the probe 200 from the housing 300 thereby keeping theground connection in place as the last signal to disengage or “break”.This type of configuration is commonly referred to as ‘make beforebreak’ and helps prevent damage to the electrical components within boththe probe 200 and housing 300 assemblies due to electro-static dischargeor capacitive discharge when engaging and disengaging these assemblies.

Referring now to FIGS. 12A and 12B, a protective cap 600 for the distalportion 230 of the probe 200 is illustrated alone and secured to thedistal portion 230 of the probe 200. The cap 600 is preferablyconstructed of an opaque material that is pliable. As illustrated inFIG. 12A, the cap 600 is in an open position. In FIG. 12B, the cap 600is in the closed position and secured to the probe 200 in the intendedmanner.

The cap 600 generally comprises a lid 610 and a base 620. The lid 610 ispivotably connected to the base 620 via hinges 601 so as to be capableof rotation about axis B-B. A latch assembly 630, 631 is provided tolock the cap 600 in a closed position.

The lid 610 comprises a bottom surface 611 and a channel 615 formed intothe bottom surface 611. The channel 615 has an open end 616 and a closedend 617. A first rim 618 protrudes from the floor 619 of the channel 615at the open end 616. A second rim 614 extends along the perimeter of thelid 610 and protrudes outward from the bottom surface 611.

Similarly, the base 620 comprises a top surface 621 and a channel 625formed into the top surface 621. The channel 625 has an open end 626 anda closed end 627. A first rim 628 protrudes from the floor 629 of thechannel 625 at the open end 626. The base 620 further comprises aplurality of legs 640 for supporting the base at a desired height.

When the lid 610 is rotated about axis B-B to the closed position, thebottom surface 611 of the lid 610 comes into contact with the topsurface 621 of the base 620. As a result, the two channels 615, 625 cometogether to collectively form an internal cavity that is sized andshaped to accommodate the distal portion 230 of the probe 200. Thisinternal cavity has an open end through which the remaining length ofthe probe 200 can protrude (as shown in FIG. 12B). The opposite end ofthe internal cavity is closed.

When the cap 600 is in the closed position, the rim 614 of the lid 610becomes compressed between the lid 610 and the top surface 621 of thebase 20 so as to form a gasket seal between the lid 610 and the base620. Similarly, when the cap 600 is in the closed position and the capis secured to the probe 200 (as shown in FIG. 12B), the rims 618, 628come together to collectively form an annular rim that acts as a gasketseal between the outer surface of the probe 200 and the floors 619, 629of the cap 600. The rims 614, 618, 628 are made of material that has asufficiently low durometer value so as to create the gasket type seals.The latch assembly 630, 631 keeps these gasket seals in tact whenlocked. As a result, when the cap 600 is closed and secured to theprobe, the distal portion 230 of the probe 200 (including the well 240)is housed in the sealed internal cavity of the cap 600. Moreover,because the cap is constructed of opaque material, this internal cavityis substantially free of visible light (i.e., it is dark).

The cap 600 serves multiple purposes in this particular aspect of theinvention. The primary function of the cap 600 is to protect the ISFET250 during storage. Scratching of the ISFET 250 can damage the ionsensitive membrane and effect operation. A secondary function of the cap600 is to create a hermetically sealed internal storage cavity about thedistal portion 230 of the probe 200 (which includes the ISFET 250,temperature sensor 260 and diaphragm 270) to keep the diaphragm 270slightly hydrated between uses. A drop of de-mineralized or distilledwater can be placed in the cap 600 once the probe 200 is laid in thechannel 625 and then sealed with the latch mechanism 330, 331.

The third function of the cap 600 is to act as a support mechanism forthe vaginal health apparatus 100 so that the sample well 240 of theprobe 200 is held level and not susceptible to tipping duringmeasurements. The legs 640 of the cap act as supports to raise the tipof the probe 200 so that the longitudinal axis A-A of the probe 200 issubstantially horizontal when the distal portion 230 of the probe 200 isresting within the channel 625. Thought of another way, because thebottom edge of the probe 200 is non-coplanar with the bottom surface 303of the handle 300, the probe 200 will have a tendency to tip/tilt. Thus,the height of the legs 640 is selected so that when the distal portion230 of the probe 200 is resting within the channel 625, the bottomsurfaces of the legs 640 are substantially coplanar with the bottomsurface 303 of the handle 300.

A fourth function of the cap 600 is to provide a cover for the ISFET 250during the sample well measurement and/or during calibration. The ISFET250 is a semiconductor device, and as such, is susceptible to UV light.Various manufacturers of ISFETs have different levels of sensitivity andgenerally measurement isn't affected greatly unless directly exposed tosunlight or high intensity lighting. However, by placing the biologicalfluid to be measured in the well 240 and securing the cap 600 to theprobe 200, the measurement will always be taken in a dark environmentwhich would reduce the potential effects of UV light impacting thereading. This “dark” environment more accurately simulates the conditionwithin the vaginal canal and cervix or of the environment of the fluidwithin the body.

Referring now to FIG. 13A, the insertion of the probe 200 into thevaginal cavity is illustrated for measuring pH within the vagina. Wheninserted, the well 240 makes contact with the vaginal wall 10. Thevaginal walls 10 make contact with each other and separate as the probe200 is inserted. The vaginal wall 10 is coated with mucus membrane witha muscular tissue underneath which then forms around the probe 200 andinto the well 240. The well 240 allows for the collection of the mucusfluids from the vaginal wall 10. The well 240 of the probe 200 istypically placed in the lower portion of the vaginal canal(approximately 1 to 2 inches). Upon the user selecting the measurementfunction via the user controls 340-342, the pH will be measured by theISFET 250 and the user will be notified with an audio tone at completionof the measurement. The measured pH will be shown on the LCD screen 330and saved within the memory device within the handle 300 (which isincorporated into the processor 510, but may be a separate device). Thisstored data is stored along with a date and time stamp so that the datacan be retrieved, analyzed and compared to later measurements accordingto known algorithms or relationships to determine a physiologicalcondition in a mammal, such as fertility status.

FIG. 13B shows the placement of the probe 200 further up the vaginalcavity and making contact with the ectocervix area of the cervix. Thewell 240 makes contact with the ectocervix and collects cervical fluidfor measurement. As stated earlier, the measurement of the cervical pHcan be a useful aid in determining the fertility cycle of the femalemammal. The probe 200 would typically be inserted about 4 to 5 inches inthe vaginal canal in order to make contact with the cervix. The deviceas shown provides a simple and reliable method of measuring the cervicalfluid to determine a condition, such as fertility status.

FIG. 14 is a graph of a 6 day plot of in-vivo vaginal pH measurementusing the above described invention. The data was gathered from a humanfemale approximately age 55 and in good health. The woman was postmenopausal and used the device daily for a period of 6 days. Readingswere sampled every 10 seconds over a 120 second period and recorded.Data was transferred from the device 100 through the RS232 serial port314 and ported into an Excel spreadsheet. The data displayed representsthe pH recorded during the test period. It shows stable readings after ashort initial settling time. The final values over the 120 secondmeasurement period were stable and within a range of 4.41 to 5.04 overthe 6 day period. No special handling or calibration was performedduring the 6 day usage other than simple cleaning with warm water.Periodic calibration with pH7 buffer utilizing a few drops in the samplewell after extended periods of non-use is recommended to guarantee theaccuracy of measurements. If the apparatus 100 were not used for anextended period of time, the logic unit 510 would notify the user toproceed with a simple calibration procedure before taking the vaginalmeasurement.

An additional test was performed to compare pH buffer measurements basedon sample size. FIG. 15 is a graph of the pH voltage measured from theapparatus 100 when the probe 200 was inserted into 25 ml of buffersolution and then compared against 0.3 cc/ml of solution placed into thesample well 240. The device 100 was allowed to stabilize for 5 minutesbefore measurements were recorded and cleaned in water and dried betweenmeasurements. A syringe was used to insure constant amount of solutionwas placed into the sample well 240. As the data shows, there is nosignificant difference in the measurement taken in the sample well 240vs. the 25 ml solution. The readings are typically within 1 mv whichconverts to a pH variance of about 0.02 pH. The data proves that thesample well 240 is of appropriate size to accurately measure smallsamples of solutions. It should be noted that in this implementation ofthe invention about 40% of the sample well area was occupied by thethermistor and therefore, it is likely that the results would be similarwith <0.2 cc/ml of solution as that is all that was required to submersethe ISFET 250 and the diaphragm 270 required for the pII measurement.

As the results above for the sample size comparisons indicate, thatthere is no significant difference in the sample size test results.Therefore a test was performed to measure urine in the sample well. Thedevice 100 was calibrated with pH7 buffer in the sample well 240 priorto the start of the test. FIG. 16 shows the results of this 4 day test.Sampling was done twice daily, once in the early morning as soon aswakening and again in later afternoon prior to a meal. No calibrationwas done during the period however an additional test was preformed onday 3 using pH7 buffer solution in place of urine. This test was done toverify the continued accuracy of the measurements since calibration wasnot preformed between urine measurements. The data shows the device 100was still accurate within 0.05 pH after 4 days of use w/o any dailycalibration required. The probe 200 was cleaned with warm water andlightly patted dry with no special storage of the probe 200 betweenuses. The data shown was sampled every 10 seconds over a 10 minute (600second) period and recorded in the memory of the logic circuit 500. Datawas transferred from the RS232 serial port 314 and imported into anExcel spreadsheet for plotting. The test subject was a 55 year old malein good health. Samples were taken in the morning and late afternoon ina small paper cup with 5 drops transferred into the sample well. The pmsamples were taken 5 hours after a mid-day meal while the am sample weretaken early in the morning before any meals and at least 10 hours afterthe last meal. The data shows stable readings throughout the measurementperiod.

FIG. 17 shows a plot of the final readings after the 10 minute periodand shows the trend line after 4 days. Diet was not recorded during thetest period to see if this had contributed to the positive trend line.It would be simple to duplicate this process over a larger test subjectsample and monitor diet to determine the effect of diet on urine pH.

The invention accurately measures small volumes of other mammalianfluids. Besides the example of urine testing explained in the textabove, examples of other fluids would be saliva or blood. By utilizingthe sample well 240, the device 100 can easily be used to monitor urinepH. A small sample of about 0.3 cc (4 or 5 drops) of urine placed in thesample well will generate an accurate urine pH reading. By utilizing theautomatic recording function on the device 100, these readings can beautomatically stored and monitored so that the user can be notified ifany significant changes have occurred over a period of time.

As mentioned above, the device 100 can be inserted further into thevagina and make contact with the ectocervix area of the cervix.Monitoring of pH of the cervix can be helpful criteria in determiningthe fertility cycle of the female. The design of the device is such thatit also monitors vaginal or cervical temperature to monitor basil bodytemperature (BBT). It is a well know fact that BBT changes as much as 1°F. during the ovulation cycle and can be used as another indicator ofthe fertility cycle. The ability of the device 100 to store both the pHand temperature readings over an extended period of time allow thedevice and software to create a profile of the female mammals menstrualcycle. The ability of the device to transfer this data to a computer canbe a valuable aid in analyzing and predicting the ovulation period forwomen with difficulty in conception.

The device 100 also monitors the vaginal pH, which can be a useful toolin the monitoring of Estrogen or Hormone Replacement Therapy (HRT).Women during or post menopause can have elevated levels of vaginal pHwithout having symptoms of BV. The device 100 can easily store thevaginal pH readings prior to and during the HRT in order to assist inthe effectiveness and regulation of Estrogen replacement therapy.

The inventive apparatus 100 is capable of measuring pH with an accuracyof 0.1 pH or better and can record measured pH values for futurereference. The device 100 has the capability of recording multiplereadings of pH value, date and time of the measurement and logging ofthese readings so that automatic user notification can be made should anunusual change in pH value occur. The amount of readings stored isstrictly dependant on the size of memory within the logic unit. It wouldbe easy and inexpensive to store hundreds of readings so that long termmonitoring is possible. This method of monitoring, recording andnotification takes the guess work out of matching colors or keeping awritten log of periodic readings. Reviewing this data and automaticallydetecting a noticeable chance can provide instant feedback to the userthat further testing or diagnostic procedures may be required especiallyif other BV symptoms occur.

The following outlines the typical measurement process when utilizingthe device 100 to measure pH and/or temperature within the vagina todetermine fertility and/or vaginal health status. The user (or otherpersonnel) will first insert the probe 200 of the device 100 into thevagina at a desired depth and alignment. If the user desires todetermine fertility status by measuring cervical pH and temperature, theuser will insert the probe 200 into the vagina until the distal portion230 of the probe 200 is adjacent and in contact with the ectocervix areaof the user. Preferably, the probe 200 is inserted so that the well 240is aligned with the ectocervix tissue and the diaphragm 270, pH sensor250 and temperature sensor 260 are aligned with and in contact with theectocervix tissue. If the user desires to determine vaginal healthstatus (such as the existence of BV or any of the other conditiondiscussed above) by measuring vaginal pH and temperature, the user willinsert the probe 200 into the vagina until the distal portion 230(including the well 240) of the probe 200 is adjacent and in contactwith the vaginal wall of the user.

Once the probe 200 is in the desired position within the vagina, theuser will initiate the measurement process by pressing the appropriatecontrol button(s) 340, 341 and/or 342 on the handle 300. When thefirmware within the microprocessor 510 (which is located in the logicunit . . . i.e., the handle housing 301) detects the control buttondepression (by receiving a measurement initiation signal) it will checkto make sure that the probe 200 is electrically connected to the handle300 through the interface connectors 417 and 517. If connected, themicroprocessor 510 will then proceed to apply power from the battery 520to the circuit 400 of the probe 200 through these interface connectors417, 517 in order to read the contents of the VPD memory 415. The powersupply from the battery 520 also enables (i.e., provides sufficientpower to) the pH and temperature sensors 250, 260 and the remainingcomponents of the circuitry 400. The processor 510 will verify that thisis a proper probe assembly and that the contents of the VPD memory 415are valid. If the firmware determines that the probe 200 has not beencalibrated for an extended period of time based on the contents of theVPD memory 415 it will indicate to the user through the LCD 330 that thesimple single point pH7 calibration process utilizing the sample well240 is required. As discussed above, the calibration process ispreferably performed in the removable cap 600 in a dark environment witha solution buffered at a known pH.

Once the microprocessor 510 detects that the device 100 is ready to takemeasurements, the user activates the user control 340-342 that sends a“take measurement signal” to the microprocessor 510. In response,microprocessor 510 initiates the pH and temperature sensors 250, 260.The pH and temperature sensors 250, 260 then generate an analog pHsignal and an analog temperature signal indicative of the measured pHand temperature within the vagina or at the ectocervix. These analog pHand temperature signals from the probe 200 are then transmitted to andprocessed through the analog to digital (A/D) converter 502. Once thecalibration or measurement cycle has started, the microprocessorfirmware 510 will determine when these A/D signals are stable and thenproceed to retrieve and use parametric data (including the slope data)from the VPD memory 415 to calculate the pH value. To determine the pHvalue, the firmware on the microprocessor 510 will read the currentmeasured temperature and utilize the slope data for the ambient 25 C.temp and the normal body 98.6 temp to determine any pH correction factorthat may be required at the current temperature. Once this calculationis complete, an output signal will be generated by the microprocessor510 that corresponds to the correct pH and temperature values. Theoutput signal is sent to the LCD 330 for viewing. This pH andtemperature information along with the date/time stamp from thereal-time clock (RTC) will also be stored in the local memory located(incorporated into the microprocessor 510) within the handle 300.

The microprocessor 510 will then proceed to update the appropriatefields within the VPD memory 415 to indicate that a measurement wastaken along with the date/time stamp of that measurement. This storedVPD information is then used for the next measurement cycle to determinehow long since the probe 200 has been used and/or how many measurementshave been taken with this particular probe.

As mentioned above, when utilizing the device to monitor vaginal health,the device 100 will be used to take pH and temperature measurements atthe lower portion of the vaginal wall as indicated in FIG. 13A. Asimilar process of verification and measurement as outlined above willoccur for the vaginal fluid captured in the sample well. These vaginalpH and temperature measurements would most likely be taken when aninstance of infection like BV, Candidiasis (yeast infection) orTrichomoniasis is suspected. These pH readings are important criteriafor diagnosing any of these infections. Continued measurements can betaken after any diagnosis to determine the effectiveness of an OTC orprescribed treatment. The device 100 will also save these readings whichcan be downloaded for analysis. Vaginal measurements need not only betaken when an instance of infection is suspected. Normal periodicmeasurements can be taken and tracked by the processing unit to notifythe user if any significant changes or trends have been detected over anextended period of time. This could be particularly useful for womenentering menopause as vaginal pH generally rises due to the decreasedamount of estrogen being produced. The firmware can detect these trendsand notify the user via the LCD 330 that a noticeable change hasoccurred and that a visit with a physician may be required.

As also mentioned above, when using the device to monitor fertilitystatus, the device 100 will be used to take the pH and temperaturemeasurements at the ectocervix area. For monitoring fertility a dailymeasurement cycle will be taken for at least one but preferably severalfemale mammalian fertility cycles. In the human female, this cycle istypically 28 days. The fertility cycle for a typical women is generallyduring a 3 day window on days 11-14 of the 28 day cycle. However inwomen who are having a difficult time conceiving this could be verynarrow window (i.e. a window of just hours) or this window could beskewed from the normal cycle (i.e. days 17-18). In the case of a verynarrow window multiple readings may need to be taken with in a shortperiod of time to provide optimal timing. After enough data has beenstored in the memory within the handle 300, the firmware can thenanalyze the stored pH, temperature and date/time stamp to determine theovulation profile of the user. Any new data then measured can becompared against this profile to determine that an ovulation cycle iseminent or present. The data from the logic unit memory could bedisplayed as an output signal as a graphical indicia on the LCD 330 toshow the ovulation cycle. If a segmented LCD display 330 is used, asimple indication that ovulation is imminent or in process would bedisplayed. This could be a flashing display or an ovulation icon. Thestored data can also be downloaded to an external device like a PC. Thisdownload function is accomplished by the user selecting the propercontrol button 340, 341 and 342 functions to initiate this data transferthrough external data ports 314 or 315.

Although an exemplary embodiment of the invention has been described indetail above, those skilled in the art will readily appreciate that theembodiment may be modified without departing from the novel advantagesof the invention. The invention is not limited to the embodimentsdisclosed, but it is intended to cover modifications within the spiritand scope of the present invention as defined by the following claims.

1. A method of determining fertility and/or vaginal health status in afemale mammal comprising: a) inserting a probe into a vagina of thefemale mammal, a distal portion of the probe comprising an ISFET formeasuring pH and a temperature sensor for measuring temperature, theprobe comprising a memory device storing parametric data unique to theISFET; b) measuring pH and temperature with the ISFET and thetemperature sensor of the probe; c) transmitting signals indicative ofthe measured pH and temperature to a microprocessor; d) themicroprocessor generating an output signal indicative of the fertilityand/or vaginal health status in the female mammal based on the signalsindicative of the measured pH and temperature and the parametric data;and e) displaying the output signal on a display device of the probe. 2.The method of claim 1 wherein the parametric data includes first ISFETslope data determined at ambient temperature and second ISFET slope datadetermined at normal body temperature.
 3. The method of claim 2 whereinthe first and second ISFET slope data is based on at least three pointsof pH parametric data.
 4. The method of claim 1 further comprising:wherein step a) comprises inserting the probe into the vagina until thedistal portion of the probe contacts an ectocervix area; wherein step b)comprises measuring pH and temperature of the ectocervix area; andstoring the measured pH and temperature values in an internal memorydevice of the probe, and time stamping the stored pH and temperaturevalues.
 5. The method of claim 4 wherein the time stamping includes dateand time of day.
 6. The method of claim 5 wherein the output signal isindicative of the fertility status in the female mammal and is alsobased on the stored pH and temperature values.
 7. The method of claim 6wherein the output signal is based on the stored pH and temperaturevalues for at least one ovulation cycle of the female mammal.
 8. Themethod of claim 6 wherein the display device is a light source and theoutput signal causes the light source to illuminate when the outputsignal is indicative of ovulation within female mammal.
 9. The method ofclaim 8 wherein the output signal does not illuminate the light sourcewhen the output signal is not indicative of ovulation within femalemammal.
 10. The method of claim 6 wherein the output signal causes afirst effect of the display device when the output signal is indicativeof ovulation within the female mammal and causes a second effect in thedisplay device when the output signal is not indicative of ovulationwithin the female mammal.
 11. A method of determining fertility and/orvaginal health status in a female mammal comprising: a) inserting aprobe into a vagina of the female mammal, a distal portion of the probecomprising a pH sensor for measuring pH and a temperature sensor formeasuring temperature, the probe comprising a first memory devicestoring parametric data unique to the pH sensor; b) measuring pH andtemperature with the pH sensor and the temperature sensor of the probe;c) transmitting signals indicative of the measured pH and temperature toa logic controller; d) the logic controller generating an output signalindicative of the fertility and/or vaginal health status in the femalemammal based on the signals indicative of the measured pH andtemperature and the parametric data; and e) communicating the outputsignal to a user.
 12. The method of claim 11 wherein the pH sensor is anISFET and the parametric data includes first ISFET slope data determinedat ambient temperature and second ISFET slope data determined at normalbody temperature.
 13. The method of claim 11 further comprising: whereinstep a) comprises inserting the probe into the vagina until the distalportion of the probe contacts an ectocervix area; wherein step b)comprises measuring pH and temperature of the ectocervix area; andstoring the measured pH and temperature values in an internal memorydevice of the probe, and time stamping the stored pH and temperaturevalues; and wherein the output signal is indicative of the fertilitystatus in the female mammal and is also based on the stored pH andtemperature values.
 14. The method of claim 13 wherein the output signalcauses a first effect when the output signal is indicative of ovulationwithin the female mammal and causes a second effect when the outputsignal is not indicative of ovulation within the female mammal.
 15. Themethod of claim 14 wherein the output signal is communicated to the userby a display device and/or an audio output device.
 16. A method ofdetermining fertility and/or vaginal health status in a female mammalcomprising: a) inserting a probe into a vagina of the female mammal, adistal portion of the probe comprising an ISFET for measuring pH and atemperature sensor for measuring temperature; b) measuring pH andtemperature with the ISFET and the temperature sensor of the probe; c)transmitting signals indicative of the measured pH and temperature to amicroprocessor; d) the microprocessor generating an output signalindicative of the fertility and/or vaginal health status in the femalemammal based on the signals indicative of the measured pH andtemperature; and e) communicating the output signal to a user.
 17. Themethod of claim 16 wherein the probe comprises a first memory devicestoring parametric data unique to the pII sensor; and wherein the outputsignal is also based on the parametric data.
 18. The method of claim 17wherein the parametric data includes first ISFET slope data determinedat ambient temperature and second ISFET slope data determined at normalbody temperature.
 19. The method of claim 18 further comprising: whereinstep a) comprises inserting the probe into the vagina until the distalportion of the probe contacts an ectocervix area; wherein step b)comprises measuring pH and temperature of the ectocervix area; andstoring the measured pH and temperature values in an internal memorydevice of the probe, and time stamping the stored pH and temperaturevalues; and wherein the output signal is indicative of the fertilitystatus in the female mammal and is also based on the stored pH andtemperature values.
 20. The method of claim 19 wherein the output signalcauses a first effect when the output signal is indicative of ovulationwithin the female mammal and causes a second effect when the outputsignal is not indicative of ovulation within the female mammal.